A prospective, single-arm study of 50 participants evaluated an extended INR follow-up interval to determine the implementation feasibility and safety of an extended interval in Veterans on a stable dose of warfarin. A protocol was designed to allow for a rigorous, yet pragmatic evaluation of a 12-week INR follow-up interval. Feasibility was determined by study enrollment, retention, and participant achievement rates for the extended INR interval. Safety was determined by bleeding and thromboembolism rates. Participants were monitored for 6 months. Despite the long-term stability of participants prior to enrollment, only 56% achieved a 12-week follow-up interval and only 34% of enrolled participants maintained a 12-week interval. Sixteen percent of participants were never eligible for an extension of their INR follow-up interval despite meeting initial enrollment criteria. There were two major bleeding events and one participant who experienced a thromboembolic event. Implementation of an extended interval of INR follow-up appears feasible as participant enrollment goals were met and pharmacists were able to follow the study protocol. However, a lower than expected proportion of participants were able to achieve and maintain an extended INR follow-up interval. Future evaluations are needed to confirm the safety of an extended INR interval.
The 2012 American College of Chest Physicians' guidelines recommended a 12-week INR follow-up interval may be appropriate for patients on stable warfarin doses. Limited evidence supports this recommendation. A single-arm, prospective cohort study over 24 months was completed in a Veterans Affairs anticoagulation clinic to determine the long-term feasibility and safety of implementing an extended INR follow-up interval in Veterans on stable doses of warfarin. Participants were required to have a stable warfarin dose for 6 months prior to enrollment. A prespecified protocol was used to titrate, extend, and manage the INR interval up to 12 weeks. Scheduling of extended INR intervals was a primary outcome. Safety outcomes included major and serious bleeding and thromboembolic events. A post-hoc comparison of baseline characteristics between individuals who were scheduled for at least 4 consecutive 12week INR follow-up intervals and those who were not was completed. Of the 50 participants, 36 (72%) were scheduled for at least one 12-week interval and 15 (30%) were scheduled for 4 consecutive intervals. There were 2 thromboembolic events that occurred in 1 participant. There were 28 major and serious bleeding events in 19 participants; 8 occurred while on the extended
Purpose To analyze the impact of a 12-week extended International Normalized Ratio (INR) follow-up interval on healthcare use. Methods A prospective cohort study of the use of an extended INR follow-up interval of up to 12 weeks was conducted over 2 years in a pharmacist-managed anticoagulation clinic. A detailed protocol was used to extend the INR follow-up interval to 5–6 weeks and then 7–8 weeks and 11–12 weeks. The number of planned and unplanned anticoagulation encounters, procedures requiring warfarin interruption, telephone triage phone calls, emergency department visits, and hospitalizations were collected. A post hoc subanalysis was also completed on participants who were scheduled for 4 consecutive 12-week intervals. Results Compared to baseline, at 12 months there was a mean decrease in planned anticoagulation encounters of 2.24 visits (p < 0.001) among 44 participants. From 12 to 24 months compared to baseline, there was a mean decrease in planned anticoagulation encounters of 3.13 visits (p < 0.001) and an increase of 0.54 unplanned anticoagulation encounters (p = 0.04) among 39 participants. The remainder of healthcare use variables were not statistically significantly different from baseline at any time point. Of the 15 participants scheduled for 4 consecutive 12-week intervals, there was a decrease from baseline of approximately 5 visits over the course of a year (p < 0.001). Conclusion An extended INR follow-up interval appears to decrease anticoagulation healthcare use without an increase in acute healthcare use. While this intervention could be cost-effective, institutions need to consider safety, efficacy, and feasibility prior to implementation.
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